Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 12:54 PM
Ignite Modification Date: 2025-12-24 @ 12:54 PM
NCT ID: NCT01585961
Description: None
Frequency Threshold: 1
Time Frame: Procedure through 7 days post-procedure
Study: NCT01585961
Study Brief: NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Catheter Ablation These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly. None None 63 508 79 508 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac perforation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sick sinus syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Catheter site hematoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Device difficult to use (foley) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subdural hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
International normalized ratio decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram ST segment depression NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hematocrit decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient global amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Femoral artery aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intra-abdominal hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Catheter site hemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fluid Overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View